Private Information Biospecimens Flowchart

1 NOT human Subjects research research Involving Private Information or Biospecimens Are the Biospecimens / Information obtained from living individuals? NO, individuals are NOT living NOT human Subjects research YES, individuals ARE living Are the Biospecimens / Information : human cell lines obtained from a commercial provider ( ATCC); or human cells about which all Information has been published; or Unidentifiable Biospecimens / Information obtained from a commercial provider; or Unidentifiable Biospecimens / Information obtained from a provider that is prohibited from releasing identifiers by established regulations or policies YES NOT human Subjects research NO Were/will the Biospecimens / Information (be) collected specifically for the proposed research through an interaction or intervention with living individuals? YES human Subjects research NO Can the recipient link the Biospecimens / Information directly to identifiable Private Information of living individuals?

2 YES human Subjects research NO Can the provider link the Biospecimens / Information directly to identifiable Private Information of living individuals? NO NOT human Subjects research YES Does the provider meet the definition of an investigator in the recipient s research ? YES, the provider is collaborating in the recipient s research human Subjects research NO, the provider is solely providing Are the Biospecimens / Information provided with a code linking them to identifiable Private Information of living individuals? NO NOT human Subjects research YES Can the recipient readily ascertain the identities of the individuals to whom the Biospecimens / Information pertain? Examples of situations in which the recipient cannot link the Biospecimens / Information to living individuals include: the key to decipher the code is destroyed before the research begins; or the investigators and the holder of the key to the code enter into an agreement preventing the release of the key to investigators under any circumstances; or there are IRB-approved written policies in place preventing the release of the key under any circumstances; or there are other legal requirements prohibiting the release of the key under any circumstances.

3 NO NOT human Subjects research YES human Subjects research Please note: this document is intended to be a resource only. Final decisions should be made in accordance with 45 CFR 46. NIH Office of Extramural research - June 25, 2019